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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002346-37 | EudraCT Number |
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This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| onabotulinumtoxinA 500U | Experimental | OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1. |
|
| onabotulinumtoxinA 300U | Experimental | OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1. |
|
| placebo (normal saline) | Placebo Comparator | Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park | Kansas | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | onabotulinumtoxinA 500U | OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1. |
| FG001 | onabotulinumtoxinA 300U | OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1. |
| FG002 | Placebo (Normal Saline) | Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | onabotulinumtoxinA 500U | OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1. |
| BG001 | onabotulinumtoxinA 300U | OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
|
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The Safety Population included all enrolled patients who received a treatment injection. The Safety Population was used to assess adverse events and serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | onabotulinumtoxinA 500U | OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| placebo (normal saline) | Drug | Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. |
|
| Baseline, Week 6 |
| Change From Baseline in Pain on an 11-Point Scale | The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Baseline, Week 6 |
| Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions. | Baseline, Week 6 |
| Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question. | Baseline, Week 6 |
| Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions. | Baseline, Week 6 |
| Montreal |
| Quebec |
| Canada |
| BG002 | Placebo (Normal Saline) | Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | onabotulinumtoxinA 300U | OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1. |
| OG002 | Placebo (Normal Saline) | Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. |
|
|
| Secondary | Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale | The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in Pain on an 11-Point Scale | The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL) | The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions. | Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received | Posted | Least Squares Mean | Standard Deviation | Scores on a Scale | Baseline, Week 6 |
|
|
|
| 2 |
| 17 |
| 4 |
| 17 |
| EG001 | onabotulinumtoxinA 300U | OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1. | 0 | 18 | 5 | 18 |
| EG002 | Placebo (Normal Saline) | Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. | 3 | 18 | 7 | 18 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.1 | Non-systematic Assessment |
|
| Electromyogram abnormal | Investigations | MedDRA version 18.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 18.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 18.1 | Non-systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA version 18.1 | Non-systematic Assessment |
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| Sialoadenitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 18.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 18.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA version 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 18.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 18.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA version 18.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Non-systematic Assessment |
|
| Pulmonary function test decreased | Investigations | MedDRA version 18.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Change from Baseline at Week 6 |
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| Change from Baseline at Week 6 |
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| Change from Baseline at Week 6 |
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| Change from Baseline at Week 6 |
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| Change from Baseline at Week 6 |
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